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510(k) K062611

IGUIDE SYSTEM by Medical Intelligence Medizintechnik-GmbH-An Elekta — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2006
Date Received
September 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Medical Intelligence Medizintechnik-GmbH-An Elekta

  • K072079 — IGUIDE SYSTEM (August 14, 2007)
  • K062639 — MODIFICATION TO HEXAPOD RT COUCH TOP (September 21, 2006)

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